Non-Invasive Brain-Computer Interface Combined With Transcranial Electrical Stimulation for Peripheral Facial PalsyStimulation in the Treatment of Peripheral Facial Palsy

Nanjing Medical University

Status: Invitation-only

Conditions: Brain-Computer Interface; Pulsed Radiofrequency; Transcranial Direct Current Stimulation; Peripheral Facial Palsy

Treatments: Procedure: Brain-Computer Interface （BCI）; Procedure: Pulsed Radiofrequency （PRF）; Other: Standard Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07327710

[2025]YLJSA075

Details and patient eligibility

About

To evaluate the efficacy and safety of treating peripheral facial palsy using a non-invasive brain-computer interface combined with transcranial direct current stimulation (tDCS).

Full description

This study is mainly designed to compare the therapeutic efficacy of non-invasive brain-computer interface combined with transcranial direct current stimulation (tDCS), pulsed radiofrequency, and pharmacological treatment versus pulsed radiofrequency combined with pharmacological treatment in patients with peripheral facial palsy.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Aged 18-70 years, regardless of sex.

Unilateral peripheral facial nerve palsy.

House-Brackmann (HB) grade II-VI.

Able to cooperate with target facial movement tasks and provide written informed consent, with intact cognitive function and good communication ability.

Good skin condition, with no severe skin lesions or facial skin grafts; no implanted electronic devices such as cardiac pacemakers or deep brain stimulators, to avoid electrophysiological interference.

Non-pregnant and non-lactating women, in accordance with regulatory requirements for minimal-risk research.

Exclusion criteria

Open facial wounds, active infections, significant skin lesions, or a history of severe allergy.

Severe cognitive impairment, psychiatric disorders, or inability to comply with study procedures.

Occurrence of serious adverse events or withdrawal at the patient's request.

Pregnant or lactating women, or patients unable to use appropriate contraceptive measures during the study period.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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30 participants in 3 patient groups, including a placebo group

Group A: Standard Therapy

Placebo Comparator group

Description:

Standard therapy.

Treatment:

Other: Standard Therapy

Group B: Pulsed Radiofrequency + Standard Therapy

Placebo Comparator group

Description:

Standard Therapy and Pulsed Radiofrequency Therapy.

Treatment:

Other: Standard Therapy

Procedure: Pulsed Radiofrequency （PRF）

Group C：BCI + tDCS + Pulsed Radiofrequency Treatment + Standard Therapy

Experimental group

Description:

BCI + tDCS + Pulsed Radiofrequency Treatment + Standard Therapy.

Treatment:

Other: Standard Therapy

Procedure: Pulsed Radiofrequency （PRF）

Procedure: Brain-Computer Interface （BCI）